FDA Accepts GPC Biotech's Satraplatin NDA for Filing and Grants Priority Review Status
GPC Biotech AG announced that the U.S. food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for satraplatin in combination with prednisone for patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed. The Company also announced that the FDA has granted the NDA priority review status. Priority review designation is intended for those products that address significant unmet medical needs and sets the target date for FDA action at six months from the date of submission. GPC Biotech completed the rolling submission of the NDA for satraplatin on February 15, 2007. The application will be reviewed under the provisions of 21 CFR 314 Subpart H, for accelerated approval.
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